Pharma and Brexit – the clock is ticking

Brexit is approaching rapidly. From 23 March 2019, the United Kingdom will no longer be a member of the European Union. Overnight, medicinal products and medical devices that do not comply with this new reality will suddenly no longer be marketable (without restrictions). Many details still remain unclear, especially the regulatory steps manufacturers will have to take with their medicinal products to avoid losing markets and revenue. Marketing authorisation holders therefore have no other option but to prepare for the worst-case scenario.

Diapharm has reported on the subject. In their publications1), 2) both the CMDh and the EMA have recommended taking active precautionary measures ahead of Brexit:

“In particular, the Commission and the European Medicines Agency / the CMDh expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes.”

However, many pharmaceutical companies appear unprepared to take these safety measures – or are in danger of underestimating the time and effort needed to do so.

If worst comes to worst, what needs to be done in the remaining time?

  • Could you end up needing a new marketing authorisation holder with the corresponding staff in the EU or in the UK?
  • Will you have to apply for a new manufacturing authorisation to import or release medicinal products?
  • Do you need a new wholesale distribution licence?
  • Is a production site transfer necessary?
  • Will you have to apply to change your reference member state – and under what circumstances may you do so?

These are just a few of the potentially most pressing issues you could face. Some of them may even have to be resolved by 29 March 2019.

Here at Diapharm, we have developed a simple decision matrix. With just a few simple questions, we can determine which regulatory steps you need to take and how much time you have to take them. We can do so for every portfolio, thereby ensuring your ability to identify and counteract the risks of Brexit at an early stage. Contact us, we are there to help!

 

1) http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_360_2017.pdf

2) http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500226603.pdf

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